1. Field of the Invention
The present invention relates to new and useful tabletable pharmaceutical compositions and methods of making the same. More particularly, the present invention relates to new and useful granular compositions containing ibuprofen which are eminently suitable for forming into tablets and methods for preparing such compositions using a fluidized bed apparatus.
2. Description of Prior Art
Ibuprofen, the generic name for 2-(4-isobutylphenyl)propionic acid, is a well known anti-inflammatory drug and is disclosed in U.S. Pat. Nos. 3,228,831 and 3,385,886.
Normally, ibuprofen is formulated for sale to the consumer in the form of compressed tablets or capsules. U.S. Pat. No. 4,609,675 discloses a method of preparing a pharmaceutical ibuprofen-containing grauulate composition suitable for preparing tablets of relatively high dosage. This is accomplished by dry mixing ibuprofen with croscarmellose sodium NF (cross-linked sodium carboxymethylcellulose) in certain relative amounts, passing the resulting mixture through a roller compactor or slugging the composition and thereafter applying a size to the resulting compacted or slugged product.
Acetaminophen, the generic name for N-acetyl-p-aminophenol, is a well known analgesic drug and is disclosed in U.S. Pat. No. 2,998,450.
U.S. Pat. No. 4,661,521 discloses a method of preparing a pharmaceutical acetaminophen-containing granulate composition suitable for shaping into tablets. This is accomplished by using a fluid bed granulator-dryer involving spraying an aqueous slurry of a portion of a pregelatinized starch onto a fluidized composition of acetaminophen and thereafter drying the same. A lubricant may be added during or after drying.
Ibuprofen-containing granules having good compressibility properties to form tablets is a desideratum of long standing. Heretofore, when granules of ibuprofen are compressed to insure good crumbling resistance, the dissolution rate of the tablets is slower than desired.